QvalFocus Inc. · 8 hours ago
GMP Technical Writer
Round Lake, IL
Contract
Onsite
Senior Level
5+ years expQvalFocus Inc. is seeking an experienced Technical Writer to support documentation and change control activities in a regulated/GMP environment. The ideal candidate will create, review, and manage complex product documentation and SOPs while ensuring compliance with GMP standards.
Staffing & Recruiting
No H1B
Hiring Manager
Prabhakar Vempati
Responsibilities
Create, edit, review, and maintain technical documentation including SOPs, work instructions, and product documentation
Support Change Control (CR) documentation from initiation through closure, ensuring accuracy, compliance, and timely execution
Manage multiple change requests simultaneously while meeting project timelines and quality standards
Collaborate with engineering, quality, manufacturing, and validation teams to gather technical information and translate it into clear, compliant documentation
Ensure all documentation adheres to GMP and internal quality system requirements
Plan, organize, and execute documentation work plans, including revisions and continuous improvements
Participate in document reviews, audits, and inspections as needed
Qualification
Required
5+ years of experience in technical writing
Strong ability to read, write, and interpret complex technical and product documentation
Excellent attention to detail and ability to understand high-level technical concepts
Experience working in a regulated and/or GMP environment
Hands-on experience with Change Control (CR) documentation
Proven ability to manage multiple CRs and competing priorities effectively
Preferred
Solid understanding of GMP concepts and core quality system processes
Familiarity with process improvement methodologies such as LEAN
Experience supporting cross-functional teams in manufacturing or life sciences environments
Strong planning, organization, and execution skills for documentation projects
Demonstrated change management and stakeholder coordination abilities
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase